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Study to Compare TP-434 and Ertapenem in CA Complicated Intra-abdominal Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01265784
First received: December 21, 2010
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections.


Condition Intervention Phase
Complicated Intra-Abdominal Infection
Drug: TP-434
Drug: Ertapenem
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety, and PK of 2 Dose Regimens of TP-434 Compared With Ertapenem in Adult Community-Acquired Complicated Intra-abdominal Infections

Resource links provided by NLM:


Further study details as provided by Tetraphase Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Clinical response of TP-434 and ertapenem in the microbiologically evaluable population [ Time Frame: Test-of-Cure Visit (10-14 days after End-of-Treatment (EOT) visit) ] [ Designated as safety issue: No ]
    Clinical response of TP-434 and ertapenem in the treatment of hospitalized subjects with cIAI at the Test-of-Cure (TOC) visit.


Secondary Outcome Measures:
  • Clinical response of TP-434 and ertapenem [ Time Frame: EOT, TOC, and Follow-up (FU) Visits ] [ Designated as safety issue: No ]
    Determine clinical response in the following populations: 1) Modified intent-to-treat (MITT) population, 2) Clinically modified intent-to-treat (c-MITT) population, 3) Microbiologically modified intent-to-treat (m-MITT) population, 4) Clinically evaluable (CE) population, 5) Microbiologically evaluable (ME) population (EOT and FU)

  • Determine microbiologic response of TP-434 and ertapenem [ Time Frame: EOT, TOC ] [ Designated as safety issue: No ]
    To determine the microbiologic response at EOT and TOC visits in the following populations: 1) m-MITT population, 2) CE population, 3) ME population

  • Assess Safety and Tolerability of TP-434 (Adverse Events, Physical Exams, Vital Signs, ECGs, Lab Data) [ Time Frame: Screening, Days 1-14, EOT, TOC, FU ] [ Designated as safety issue: Yes ]
    Describe the safety profile of TP-434 in the MITT population

  • Explore the PK of TP-434 and ertapenem [ Time Frame: Day 1, Day 3, Day 5 ] [ Designated as safety issue: No ]
    Evaluate the Pharmacokinetics of TP-434


Enrollment: 143
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TP-434, 1.5 mg/kg q24h
TP-434, 1.5 mg/kg q24h administered via IV infusion, plus saline placebo
Drug: TP-434
TP-434 reconstituted and administered via an IV infusion
Experimental: TP-434, 1.0 mg/kg q12h
TP-434, 1.0 mg/kg q12h administered via IV infusion, plus saline placebo
Drug: TP-434
TP-434 reconstituted and administered via an IV infusion
Active Comparator: Ertapenem 1 g q24h
Ertapenem, 1 g q24h administered via IV infusion, plus saline placebo
Drug: Ertapenem
Ertapenem reconstituted and administered via an IV infusion
Other Name: Invanz®

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Abdominal pain/discomfort with onset prior to hospitalization
  • Evidence of a systemic inflammatory response
  • Physical findings consistent with intra-abdominal infection (IAI)
  • Clinical diagnosis of community-acquired intra-abdominal infection requiring urgent surgical or percutaneous intervention and not expected to require antibacterial therapy for longer than 14 days
  • Body mass index (BMI) of ≤ 30 kg/m2
  • Able to provide informed consent. If the patient is unable to provide informed consent, the patient's legally acceptable representative may provide written consent in accordance with institutional guidelines
  • If female, not pregnant or nursing or, if of child-bearing potential either: will commit to use at least two medically accepted, effective methods of birth control (e.g., condom, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) during study drug dosing and for 90 days following last study drug dose or practicing sexual abstinence

Exclusion Criteria:

  • Symptoms related to diagnosis of complicated appendicitis (if current diagnosis) for < 24 hrs prior to current hospitalization
  • Previously hospitalized or admitted to a healthcare facility within the last 6 months
  • Managed by Staged Abdominal Repair or other open abdomen technique
  • Known at study entry to have an IAI caused by a pathogen(s) resistant to both study drug antibiotics
  • APACHE II score > 25
  • Unlikely to survive the 6-8 week study period
  • Any rapidly-progressing disease or immediately life-threatening illness, including acute hepatic failure, respiratory failure and septic shock
  • Requirement for vasopressors at therapeutic dosages
  • Renal failure
  • Presence or possible signs of hepatic disease
  • Hematocrit < 25% or hemoglobin < 8 g/dL
  • Neutropenia with absolute neutrophil count < 1000/mm3
  • Platelet count < 50,000/mm3
  • Abnormal coagulation tests or patient on anticoagulants
  • Immunocompromised condition, including known HIV positivity or AIDS, organ (bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (e.g., > 40 mg prednisone or equivalent per day for greater than 2 weeks)
  • History of hypersensitivity reactions to tetracyclines or carbapenems
  • Participation in any investigational drug or device study within 30 days prior to study entry
  • Known or suspected central nervous system (CNS) disorder that may predispose to seizures or lower seizure threshold
  • Previously received TP-434 in a clinical trial
  • More than 24 hrs duration of systemic antibiotic coverage for current condition or received ertapenem or any other carbapenem, or tigecycline for the current infection or
  • Need for concomitant systemic antimicrobial agents other than study drug or received systemic (IV or oral) antibiotics in the last 3 months
  • Refusal of mechanical ventilation, dialysis or hemofiltration, cardioversion or any other resuscitative measures and drug/fluid therapy at time of consent
  • Known or suspected inflammatory bowel disease or associated visceral abscess
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265784

  Show 38 Study Locations
Sponsors and Collaborators
Tetraphase Pharmaceuticals, Inc.
Investigators
Study Director: Patrick T Horn, MD, PhD Tetraphase Pharmaceuticals, Inc.
  More Information

No publications provided by Tetraphase Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01265784     History of Changes
Other Study ID Numbers: TP-434-P2-cIAI-1
Study First Received: December 21, 2010
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Infection
Intraabdominal Infections
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014